This short report provides details of the regulatory requirements and operational considerations when conducting non-interventional studies (NIS) in Mexico.Mexico-map-colour

  • Title: NIS Considerations – Mexico (2015)
  • Publication Date: 24 November 2015
  • No. of Pages: 2o
  • Format: PDF
  • Author/ Editor: Stuart McCully

Table of Contents:

  1. DISCLAIMER
  2. REGULATORY BODIES
  3. SUMMARY OF THE COUNTRY-SPECIFIC REGULATORY REQUIREMENTS
  4. REGULATORY SUBMISSIONS DOCUMENTS
    1. Regulatory Submissions Document Checklist
    2. Which Documents Need to Be Translated?
    3. Who is Responsible for What?
  5. STUDY CONDUCT CONSIDERATIONS
  6. APPLICABLE LEGISLATION AND GUIDELINES
  7. USEFUL LINKS
    1. Regulatory Requirements
    2. Data Privacy Considerations
    3. Study Conduct Considerations
    4. Best Practice Considerations
  8. ANNEX 1: TEMPLATE COVER LETTER

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